The median time to relapse among subjects in clinical remission at baseline. Relapse is defined as increase in CDAI of >100 points from the baseline and an absolute CDAI score of >220 points. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]

CDAI scores over time and change from baseline in CDAI scores. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]

The proportion of subjects achieving a steroid-free clinical remission at Week 48 among subjects on steroids at baseline. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Recruiting

Estimated Enrollment ICMJE

85

Estimated Completion Date

August 2016

Estimated Primary Completion Date

July 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).

Women of childbearing potential must test negative for pregnancy prior to study enrolment.

Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.

Exclusion Criteria:

Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.

Subjects who were discontinued from the A3921084 study due to an adverse event.

Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).